Offer summary
Qualifications:
BS in Science, Engineering or equivalent, 5+ years experience in Design Quality or related field, Advanced knowledge of FDA, ISO requirements, Experience in regulated laboratory and product development, Molecular diagnostics background preferred.
Key responsabilities:
- Lead Design Quality and Risk Management programs
- Provide Quality oversight for compliance and processes
- Review and approve Design History File elements
- Train and mentor teams on Quality Management System
- Support cross-functional teams with regulatory inspections